Safety - Pharma Rep Focus

Safety Signal in Phase 2 Deals a Setback to BioAge Labs’ Muscle-Preserving Obesity Drug

MedCity News

DECEMBER 8, 2024

BioAge Labs said the potential safety problem was observed in some who received experimental drug azelaprag, which is being tested as a monotherapy and in combination with Eli Lilly obesity medication Zepbound. No safety signals were observed in those who received Zepbound alone.

Safety

Safety Medical Biopharma Pharma

Safety Risk Sinks Cargo Therapeutics’ Cancer Cell Therapy Prospect, Leading to 50% Staff Cut

MedCity News

JANUARY 30, 2025

The post Safety Risk Sinks Cargo Therapeutics Cancer Cell Therapy Prospect, Leading to 50% Staff Cut appeared first on MedCity News. Phase 2 data for Cargo Therapeutics CD22-targeting cell therapy show low durability and cases of a severe immune response, some that were classified as grade 4 or 5 serious adverse events.

Prospecting

Prospecting Safety Leads Biopharma

Safety Stands Out in Arcellx Cell Therapy’s ASH Data, But Don’t Overlook Manufacturing Advantages

MedCity News

DECEMBER 10, 2024

The post Safety Stands Out in Arcellx Cell Therapys ASH Data, But Dont Overlook Manufacturing Advantages appeared first on MedCity News. Arcellx is developing its CAR T-treatment under a partnership with Gilead Sciences.

Safety

Safety Manufacturing Biopharma Pharma

Pfizer Stops Work on Oral GLP-1 Obesity Drug After Safety Signal Surfaces in Clinical Trial

MedCity News

APRIL 14, 2025

Pfizer is stopping further work on this program, a move that comes nearly two years after it discontinued development of a different obesity drug due to liver safety signals in a clinical trial. The post Pfizer Stops Work on Oral GLP-1 Obesity Drug After Safety Signal Surfaces in Clinical Trial appeared first on MedCity News.

Safety

Safety Patients Biopharma Pharma

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Revvity Signals provides a centralized analytics platform built to support today’s clinical study requirements and increase trial efficiency, glean actionable analytic insights, automate data collection and harmonization, support safety and efficacy decision-making, and enable a singular view across a company’s entire candidate portfolio.

Safety

FDA Pushes Out Decision for Cytokinetics Heart Drug to Review Proposed Safety Plan

MedCity News

MAY 2, 2025

The post FDA Pushes Out Decision for Cytokinetics Heart Drug to Review Proposed Safety Plan appeared first on MedCity News. Analysts say this development could signal a change in FDA thinking about risk management for the broader drug class.

Safety

Safety FDA Management Biopharma

Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit

Fierce Pharma

JUNE 18, 2024

Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.

Safety

Staff Safety is Key to Sustaining Home Health Growth

MedCity News

OCTOBER 1, 2024

Innovative approaches to home care will only be successful if organizations can ensure the safety of the professionals who enter patient homes. The post Staff Safety is Key to Sustaining Home Health Growth appeared first on MedCity News.

Safety

Safety Patients Healthcare Healthcare

Patient Safety Structural Measure Marks Progress Towards Safer and Compassionate Care

MedCity News

OCTOBER 1, 2024

CMS recently finalized the Patient Safety Structural Measure, which sets forth a broad roadmap for the implementation of a culture of safety, learning, transparency and accountability within hospitals and health systems nationwide — enabling and encouraging significant progress towards safer care and improved support for healthcare workers.

Safety

Safety Patients Healthcare Healthcare

How Machine Learning Drives Clinical Trial Efficiency

Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Safety

Right-to-Repair Laws Could Threaten Healthcare Safety

MedCity News

MAY 14, 2024

The post Right-to-Repair Laws Could Threaten Healthcare Safety appeared first on MedCity News. Healthcare devices must be exempted from general right to repair legislation.

Safety

Safety Healthcare Healthcare

AI Is at the Intersection of Safety and Equity in Healthcare

MedCity News

MARCH 24, 2023

This means that the effective and equitable use of AI will be based on solving inherent ethical, safety, data privacy and cybersecurity challenges. Hidden biases, reduced privacy, and over-reliance on non-transparent, decision-making black boxes can cut against democratic values, potentially putting our civil rights at risk.

Safety

Safety Ethics Healthcare Healthcare

Novo Nordisk, Eli Lilly face scrutiny from EU's drug regulator over GLP-1 safety

Fierce Pharma

JUNE 22, 2023

The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.

Safety

'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Fierce Pharma

NOVEMBER 1, 2024

Now, less than a year later, the FDA is reconsidering those serious safety warnings with plans to potentially change them, CBER Director Peter Marks, M.D., . | An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry.

FDA

FDA Safety Pharma Patients

Commercial Drug Sourcing for Clinical Trials

Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others.

Medical

From Recalls to Reliability: Tools to Ensure Software Safety in MedTech

MedCity News

JUNE 14, 2024

The post From Recalls to Reliability: Tools to Ensure Software Safety in MedTech appeared first on MedCity News. Cutting-edge technology empowers developers to proactively detect and mitigate issues before they cause problems, reducing recalls and fostering trust in the industry.

Safety

Safety Patients Medical

AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Fierce Pharma

NOVEMBER 20, 2024

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

Safety

Safety FDA

The Value-based Care Throughline to Healthcare Quality and Safety

MedCity News

MAY 27, 2024

The post The Value-based Care Throughline to Healthcare Quality and Safety appeared first on MedCity News. By prioritizing continuous patient engagement and strategic communication across the entire care journey, healthcare organizations can drive real progress toward value-based care.

Safety

Safety Healthcare Healthcare Patients

4 Steps Needed to Improve Patient Safety On a National Level, Per PCAST

MedCity News

SEPTEMBER 7, 2023

The President’s Council of Advisors on Science and Technology (PCAST) issued a report that laid out four recommendations to improve patient safety across the nation. Some of these included creating federal leadership positions focused on advancing patient safety and hastening research on systems of safe care.

Safety

Safety Patients Healthcare Healthcare

VBC Won’t Save Safety Net Hospitals, Experts Say

MedCity News

APRIL 24, 2023

A shift from fee-for-service payment models to value-based models is not an effective way to address the severe financial pressures that safety net hospitals are facing, experts argued at the HIMSS conference in Chicago. One called for a paradigmatic shift “away from cost savings and toward understanding where investments are needed.”

Safety

EMA Committee’s Negative Opinion for Eisai Alzheimer’s Drug Focuses on Safety Risks

MedCity News

JULY 26, 2024

The post EMA Committee’s Negative Opinion for Eisai Alzheimer’s Drug Focuses on Safety Risks appeared first on MedCity News. The EMA’s Committee for Medicinal Products for Human Use expressed concern about brain complications associated with the Eisai Alzheimer’s drug, Leqembi.

Safety

Safety Medicine Biopharma Pharma

Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

MedCity News

APRIL 15, 2024

The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News. The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia.

Safety

Safety FDA Leads Biopharma

‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

MedCity News

NOVEMBER 10, 2024

While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability. Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia.

FDA

FDA Engineering Safety Biopharma

Medication Management Technology Puts Patient Safety at the Center of Care

MedCity News

FEBRUARY 21, 2024

In the same way that airbags were a natural evolution of vehicle safety technology, seamless, RFID-based systems are the next evolution of medication management technology.

Safety

Safety Management Medical Patients

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices

Fierce Pharma

JANUARY 17, 2023

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. Tue, 01/17/2023 - 11:49.

Safety

Safety Plans are Effective at Reducing Suicidal Behavior. So Why Aren’t More People Getting Them?

MedCity News

JULY 7, 2024

In addition to making suicide screening more accessible and widespread, successful implementation of safety plans is critical — here are 3 recommendations that care teams can implement. The post Safety Plans are Effective at Reducing Suicidal Behavior. So Why Aren’t More People Getting Them? appeared first on MedCity News.

Safety

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety

Fierce Pharma

MAY 17, 2023

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety aliu Wed, 05/17/2023 - 12:29

Safety

Safety FDA

Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors

MedCity News

NOVEMBER 12, 2024

Neurogene’s Rett syndrome gene therapy has preliminary data supporting safety and efficacy of the one-time treatment. But a late-breaking report of a serious complication in a patient who received the high dose sent shares of the biotech downward.

Safety

Safety Patients Biopharma

MedCity Pivot Podcast: Embedding a New Data Safety Standard in Healthcare

MedCity News

JANUARY 31, 2025

The post MedCity Pivot Podcast: Embedding a New Data Safety Standard in Healthcare appeared first on MedCity News. We kick off our first season of the MedCity Pivot Podcast by discussing ways healthcare organizations can protect themselves from being targets of a cybersecurity attack. A new IEEE Standard can help.

Safety

Safety Healthcare Healthcare

Why We Need a New Category for Safety Devices

MedCity News

FEBRUARY 26, 2023

Creating a category for technologies like the safety release valve would confer benefits, including improved patient safety, reduced costs for the healthcare system overall, and lowered liability risk.

Safety

Safety Healthcare Healthcare Patients

Inside Healthcare’s Hottest New AI Category: Agentic AI

MedCity News

MARCH 9, 2025

While initial adoption is focused mainly on non-clinical areas like scheduling and prior authorizations, experts predict that AI agents could eventually play a role in clinical decision-making, provided they meet rigorous safety and reliability standards.

Safety

Safety Healthcare Healthcare Physicians

Novartis Tries Again in Huntington’s, Putting Up $1B to Partner on a PTC Therapeutics Drug

MedCity News

DECEMBER 2, 2024

Last year, Novartis discontinued its Huntington’s program after safety issues emerged in Phase 2 testing. Novartis is securing global rights to a PTC Therapeutics Huntington’s disease drug candidate that has encouraging Phase 2 data that will be discussed with the FDA to plan a pivotal study.

Safety

Safety FDA Biopharma Pharma

After Covis' Makena pull, EU regulator flags safety and efficacy problems with similar preterm birth drugs

Fierce Pharma

MAY 17, 2024

A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns. Following a controversy over Covis’ preterm birth drug Makena in the U.S.

Safety

Safety Medicine

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

MedCity News

JANUARY 23, 2024

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.

Safety

Safety FDA Patients Biopharma

Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

Fierce Pharma

JANUARY 24, 2024

Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. . | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Instead, it's adjusted the wording of a proposed boxed warning.

Safety

Safety FDA

Eisai Alzheimer’s Drug Wins Full FDA Approval, But With Sterner Safety Alert

MedCity News

JULY 6, 2023

While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks. Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval.

Safety

Safety FDA Biopharma Pharma

Pediatric Mental Health Crisis Tops ECRI’s List of 2023 Patient Safety Concerns

MedCity News

MARCH 13, 2023

Each year, nonprofit ECRI creates a list of the industry’s top ten patient safety concerns. This year, the pediatric mental health crisis topped the list, above other important issues like violence against healthcare staff and clinicians being expected to work outside their scope of practice.

Safety

Safety Patients Healthcare Healthcare

Connected Care, Shared Goals: Designing Whole-Person Care for Complex Patient Populations

MedCity News

MAY 18, 2025

As the safety-net landscape shifts and funding uncertainty grows, the path forward is clear.

Patients

Patients Safety

Why Sentara Health Invested $11M Into iPhones for Nurses

MedCity News

JANUARY 24, 2025

The program has been going on for a little more than a year and Amy Rosa, the health systems chief nursing informatics officer, says the initiative is already resulting in increased efficiency, documentation accuracy and patient safety. The post Why Sentara Health Invested $11M Into iPhones for Nurses appeared first on MedCity News.

Safety

Safety Patients Healthcare Healthcare

Clarity will help stem the problem of ‘winners and losers’ in medical device safety and security

MedCity News

JUNE 22, 2022

The Clarifying Remanufacturing to Protect Patient Safety Act was introduced by Reps. Scott Peters (D-CA), Kim Schrier (D-WA), and John Joyce (R- PA) to clarify the meaning of medical device remanufacturing and empower the FDA to educate company technicians so they know if they’ve crossed the line into a regulated activity. .

Safety

Safety Medical Education FDA

Solving the nursing crisis starts with psychological safety

MedCity News

JULY 13, 2022

When thinking about gratitude for nurses who have carried our nation over the last two-plus years, it’s going to take a lot more than a pizza party during Nurses Month to show them we care.

Safety

Viking Therapeutics’ Early Clinical Data Continue to Build Case for Its Oral Obesity Drug

MedCity News

NOVEMBER 4, 2024

Higher doses of a Viking Therapeutics pill that targets two receptors led to greater weight loss without worsening safety or tolerability, according to Phase 1 results presented during the ObesityWeek conference. Meanwhile, an injectable version of this Viking drug is on track to Phase 3 testing.

Safety

Safety Biopharma

New study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

Fierce Pharma

AUGUST 20, 2024

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

Safety

6 Questions To Ask Before Integrating AI Into A Clinical Workflow

MedCity News

JUNE 16, 2025

As the adoption of artificial intelligence (AI) advances in healthcare, key considerations can help validate that the technology is purpose-built to help clinicians protect patient safety. The post 6 Questions To Ask Before Integrating AI Into A Clinical Workflow appeared first on MedCity News.

Safety

Safety Healthcare Healthcare Patients

Safety Signal in Phase 2 Deals a Setback to BioAge Labs’ Muscle-Preserving Obesity Drug

Safety Risk Sinks Cargo Therapeutics’ Cancer Cell Therapy Prospect, Leading to 50% Staff Cut

Trending Sources

Safety Stands Out in Arcellx Cell Therapy’s ASH Data, But Don’t Overlook Manufacturing Advantages

Pfizer Stops Work on Oral GLP-1 Obesity Drug After Safety Signal Surfaces in Clinical Trial

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

FDA Pushes Out Decision for Cytokinetics Heart Drug to Review Proposed Safety Plan

Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit

Staff Safety is Key to Sustaining Home Health Growth

Patient Safety Structural Measure Marks Progress Towards Safer and Compassionate Care

How Machine Learning Drives Clinical Trial Efficiency

Right-to-Repair Laws Could Threaten Healthcare Safety

AI Is at the Intersection of Safety and Equity in Healthcare

Novo Nordisk, Eli Lilly face scrutiny from EU's drug regulator over GLP-1 safety

'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Commercial Drug Sourcing for Clinical Trials

From Recalls to Reliability: Tools to Ensure Software Safety in MedTech

AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

The Value-based Care Throughline to Healthcare Quality and Safety

4 Steps Needed to Improve Patient Safety On a National Level, Per PCAST

VBC Won’t Save Safety Net Hospitals, Experts Say

EMA Committee’s Negative Opinion for Eisai Alzheimer’s Drug Focuses on Safety Risks

Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

Medication Management Technology Puts Patient Safety at the Center of Care

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices

Safety Plans are Effective at Reducing Suicidal Behavior. So Why Aren’t More People Getting Them?

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety

Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors

MedCity Pivot Podcast: Embedding a New Data Safety Standard in Healthcare

Why We Need a New Category for Safety Devices

Inside Healthcare’s Hottest New AI Category: Agentic AI

Novartis Tries Again in Huntington’s, Putting Up $1B to Partner on a PTC Therapeutics Drug

After Covis' Makena pull, EU regulator flags safety and efficacy problems with similar preterm birth drugs

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

Eisai Alzheimer’s Drug Wins Full FDA Approval, But With Sterner Safety Alert

Pediatric Mental Health Crisis Tops ECRI’s List of 2023 Patient Safety Concerns

Connected Care, Shared Goals: Designing Whole-Person Care for Complex Patient Populations

Why Sentara Health Invested $11M Into iPhones for Nurses

Clarity will help stem the problem of ‘winners and losers’ in medical device safety and security

Solving the nursing crisis starts with psychological safety

Viking Therapeutics’ Early Clinical Data Continue to Build Case for Its Oral Obesity Drug

New study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

6 Questions To Ask Before Integrating AI Into A Clinical Workflow

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